In this role you are primary responsible for validation studies executed conform site standards and the companies' guidelines.
The studies you’re working on must meet the quality requirements. This function encompasses cleaning, mixing and sterilization validation of production equipment.
- You are responsible to maintain and continue to improve the validation process. This includes defining and developinng new validation strategies for the implementation of new equipment and NPIs.
- You will train and coach engineers in GMP compliance and perform the internal review of protocols and reports.
- You are responsible for preparation of protocols and execution of studies. Lead and support the coordination of studies.
- You’ll participate in multidisciplinary projects as independent core team member to represent TO.
- Assessment of change controls and preparing of validation assessments.
- You lead and support in deviation investigations.
- Must have Bachelor or Master in Science (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, Engineering).
- Must have 3+ year relevant experience in the (bio-) pharmaceutical industry.
- Precise, accurate, structured, flexible and customer focused.
- Proven experience with GMP and compliance.
- Expertise in process excellence and/or project management is a plus.
- Good communicative skills in English language (writing and verbal), Dutch is considered a plus.
A great role at a large pharmaceutical company.
Contactpersoon voor deze functie is Peter Debrichy, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: firstname.lastname@example.org Kenmerk: 9027.